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FDA approves first DES for use in patients with MI
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Boston Scientific has announced that its ION paclitaxel-eluting chromium coronary stent system and Taxus Liberte paclitaxel-eluting coronary stent system have received FDA approval for use in patients experiencing an acute MI. Currently, they are the only drug-eluting stent systems in the US with an approved indication to treat patients with acute MI, according to a press release issued by the manufacturer.
The FDA based its approval on a review of data from the Paclitaxel (Taxus) clinical program and HORIZONS-AMI trial. In the global HORIZONS-AMI trial, 3,006 patients were randomly assigned to receive either DES or bare metal stents for the treatment of acute MI, making it the largest randomized trial to study coronary stents in MI patients.
“The acute MI indication is a testament to our long-term commitment to innovation and leading clinical science in support of advanced DES technologies,” Keith D. Dawkins, MD, global chief medical officer for Boston Scientific, said in the release. “Clinical data from the HORIZONS-AMI trial showed that, in patients with acute MI, paclitaxel-eluting stents were superior in efficacy to bare metal stents, significantly reducing clinical and angiographic restenosis compared to bare metal stents, while demonstrating a comparable safety profile at 3 years. We are proud that our investments in randomized trials such as HORIZONS-AMI have led to the approval of products to treat a broader range of patients with coronary artery disease.”
The manufacturer’s ION stent system incorporates a unique platinum chromium alloy designed specifically for coronary stenting and is intended to improve the acute performance of coronary stent implantation in the treatment of CAD.
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